Innovent Announces First Patient Dosed in a Phase I Clinical Trial of Anti-CD47 Monoclonal Antibody
- Category: Antibodies
- Published on Tuesday, 15 January 2019 12:03
- Hits: 1285
SUZHOU, China I January 14, 2019 I Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, announced today that the first patient has been successfully dosed in a phase I clinical trial of anti-CD47 monoclonal antibody (IBI188) for patients with advanced malignancies.
The study is a phase I clinical study conducted in China to evaluate the safety, tolerability, and efficacy of IBI188 in the treatment of patients with advanced malignancies. The primary objectives are to evaluate the safety, tolerability, and phase II recommended doses of IBI188 as a monotherapy and in combination with other agents in subjects with advanced malignancy.
"CD47 is a 'don't eat me' signal; the CD47-SIRPα mechanism is hijacked in many malignant tumors to escape immune mediated clearance. Based on the promising safety and efficacy data from literature, we hope to validate the therapeutic value of IBI188 monoclonal antibody in advanced malignancies," said Professor Jun Zhu, from the Beijing Cancer Hospital.
"IBI188 is a pivotal product in our pipeline of cancer immunotherapies. CD47 is an important component of a critical inhibitory immune pathway but is different from T cell check point inhibitors such as PD-1, PD-L1 and CTLA-4. CD47 targets macrophages and suppresses phagocytosis by interacting and activating the inhibitory receptor SIRPα. Anti-CD47 mono therapy and combination therapy has shown promising efficacy in several types of solid tumor and in refractory/relapsed non-Hodgkin Lymphoma. We are preparing to advance IBI188 into subsequent clinical trials in a variety of cancers once its safety, tolerability and the recommended phase II dose are confirmed. We hope our efforts will give more patients the opportunity for tumor control or even cure," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.
IBI188 is a fully human monoclonal antibody targeting CD47. In vitro and in vivo experiments have shown that IBI188 can bind to the CD47 antigen on the surface of tumor cells, block the CD47-SIRPα signaling pathway, inhibit the "Don't Eat Me" signal, and promote the phagocytosis of tumor cells by macrophages, thereby exerting an anti-tumor effect. Innovent will launch several clinical trials to assess its safety and efficacy in multiple tumor types, including non-Hodgkin's lymphoma and ovarian cancer.
The CIBI188A101 study is a Phase I clinical study conducted in China to evaluate the safety, tolerability, and efficacy of IBI188 in the treatment of patients with advanced malignancies. The primary objectives are to evaluate the safety, tolerability, and phase II recommended doses of IBI188 as a monotherapy and in combination with other agents in subjects with advanced malignancy. The phase 1a study explores the priming and maintenance dose of IBI188 as monotherapy.
Innovent was established in 2011. Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. These capabilities have enabled the company to build a robust pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune, and cardiovascular diseases. Leveraging the platform, the company has built up a pipeline of 20 innovative medicines in the last seven years, led by four core products that are in late-stage clinical development in China. Out of the pipeline of 20 innovative medicines, thirteen have entered into clinical development, four have entered Phase III clinical trials, one (biosimilar to Humira) has its New Drug Application (NDA) under review and Tyvyt® (sintilimab injection) is now approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL).
Innovent has built a biopharmaceutical production facility that operates under global standards. The design and operation of the clinical and commercial facilities are in compliance with the cGMP standards of NMPA, FDA and EMA. The existing production lines have already passed GMP audits by an international pharmaceutical company. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, Incyte, Hanmi and other biopharmaceutical companies.
Inspired by the spirit of "Start with Integrity, Succeed through Action", Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Innovent wishes to work with all relevant parties helping the advancement of China's biopharmaceutical industry, improving the drug availability to ordinary people and enhancing the quality of the patients' life.
Innovent is listed on the main board of the Hong Kong Stock Exchange with the stock code of HK 01801.
SOURCE: Innovent Biologics